Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OCT 2019-01-22

AMD Anti-Fog Solution

Applicant Advanced Medical Design Co., Ltd.

K-Number K181887

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NJM 2019-01-22

S-Line

Applicant Biocetec Co., Ltd.

K-Number K182193

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LNH 2019-01-22

O-Scan

Applicant Esaote, S.p.A.

K-Number K183685

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OHS 2019-01-22

LG PRA.L DERMA LED MASK

Applicant Lg Electronics.Inc

K-Number K183671

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FBN 2019-01-22

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

Applicant Boston Scientific Corporation

K-Number K183636

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FLL 2019-01-22

FEMON Banana Thermometer

Applicant Life Science Technology, Inc.

K-Number K180767

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IYN 2019-01-22

HM70A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K182894

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NKG 2019-01-22

M.U.S.T. Mini Extension

Applicant Medacta International S.A.

K-Number K182837

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PDU 2019-01-21

XableCath Crossing Catheter

Applicant Xablecath, Inc.

K-Number K183357

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MBI 2019-01-21

Tigon Medical Tissue Anchors

Applicant Tigon Medical

K-Number K182507

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HBF 2019-01-20

Codman Disposable Perforators

Applicant Integra Lifesciences Corp.

K-Number K183581

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HBE 2019-01-19

ELAN 4 Tools

Applicant Aesculap, Inc.

K-Number K182527

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